Code of China Chinese Standard Classification Professional Classification ICS Classification Latest
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YY/T 1512-2017 Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process 225.0 via email in 1~3 business day valid
YY/T 0639-2008 In Vitro Diagnostic Medical Devices-Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology 174.0 via email in 1~3 business day valid
YY/T 0618-2017 Test methods for bacterial endotoxins of medical devices―Routine monitoring and alternatives to batch testing 495.0 via email in 1~5 business day valid
YY/T 0872-2013 Test methods for ureteral stents 210.0 via email in 1~3 business day valid
GB 16174.1-2015 Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer 200.0 via email in 1~3 business day valid
GB/T 16886.5-1997 Biological evaluation of medical devices--Part 5:Tests for cytotoxicity:in vitro methods 165.0 via email in 1~3 business day superseded
GB/T 16886.12-2000 Biological evaluation of medical devices-Part 12:Sample preparation and reference materials 490.0 via email in business day abolished
YY/T 0878.1-2013 Complement activation test for medical devices - Part 1: Serum complement activation 150.0 via email in 1~3 business day valid
YY/T 0171-2008 Surgical instruments - Packaging, Marking and Instructions 105.0 via email in 1~3 business day valid
GB/T 16886.13-2001 Biogical evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices 150.0 via email in 1~3 business day abolished
GB/T 16886.10-2000 Biological evaluation of medical devices-Part 10:Tests for irritation and sensitization 1310.0 via email in business day abolished
YY/T 0870.5-2014 Test for genotoxicity of medical devices―Part 5:Mammalian bone marrow chromosome aberration test 165.0 via email in 1~3 business day valid
YY/T 0993-2015 Biological evaluation of medical devices―Nanomaterial:In vitro cytotoxicity tests(MTT assay and LDH assay) 150.0 via email in 1 business day valid
YY/T 0618-2007 Bacterial endotoxins—Test methodologies routine monitoring and alternatives to batch testing 345.0 via email in 1~5 business day superseded
GB/T 19702-2005 In vitro 180.0 via email in 1~3 business day valid
YY 0466-2003 Medical devices -- Symbols to be used with medical device labels labelling and information to be supplied 130.0 via email in 1~3 business day abolished
GB/T 16886.19-2011 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials 260.0 via email in 1~3 business day valid
YY/T 0616.1-2016 Medical gloves for single use―Part 1:Requirements and testing for biological evaluation 440.0 via email in 1~5 business day valid
YY/T 0176-2006 Surgical Scissors—General specifications 75.0 via email in 1~3 business day valid
GB/T 16294-2010 Test method for settling microbe in clean room(zone) of the pharmaceutical industry 160.0 via email in 1 business day valid
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